Industry View on EFSA Environmental Guidance Document Development and Recent Experiences with Opinions & Guidance Dr Peter Campbell.

Industry View on EFSA Environmental Guidance

Document Development and Recent Experiences with Opinions

& Guidance

Dr Peter Campbell

• Purpose of Guidance

• Review of Existing Guidance

• Experience with recent EFSA Guidance

Protected Crops, Birds & Mammals, Aquatic Organisms & Bees

• EFSA Plans for New Guidance & Opinions

Potential future problematic areas – NT Plants & NT Arthropods

• General lessons learned

• Conclusions & Recommendations

Presentation Outline

Provide a Risk Assessment Framework

• Science Based

• Fit for purpose

• Robust

• Protective

• Harmonized

Risk Assessment Outcome should be:

• Predictable - along the development and regulatory timelines

• Practicable

• Consistent

Purpose of Guidance Documents

• SETAC Guidance e.g.:

• EPPO Scheme for the environmental risk assessment

of plant protection products

Env PPP Guidance Prior to SANCO/EFSA

FATE and BEHAVIOUR in the ENVIRONMENT:

•SANCO/9188/VI/98-rev 8, "Guidance Document on Persistence in Soil", 2000

•SANCO/4802/2001-rev.1 “FOCUS Surface Water Scenarios in the EU Evaluation Process under 91/414/EEC”, 2002

•SANCO/321/2000 rev.2, “FOCUS Groundwater Scenarios in the EU Review of Active Substances”

•Generic guidance for FOCUS Groundwater Scenarios version:1.1, 2002

•SANCO/221/2000-rev 10, "Guidance Document on Relevant Metabolites in Groundwater", Feb. 2003

Ecotoxicology:

•SANCO/10329/2002-rev 2 final, "Guidance Document on Terrestrial Ecotoxicology", 2002

•SANCO/4145/2000, "Guidance Document on Risk Assessment for Birds and Mammals", 2002

•SANCO/3268/2001-rev 4 final, "Guidance Document on Aquatic Ecotoxicology", 2002

Existing EC PPP Env Guidance

• EFSA GD Risk Assessment for Birds and Mammals

• EFSA GD on Tiered Risk Assessment for Aquatic Organisms at edge of field

• EFSA GD on Emissions from Protected Crops

• EFSA GD on Risk Assessment for Bees – not adopted yet

Recent EFSA Environmental Guidance Documents for PPPs

Recent Experience EFSA Guidance Document on Birds & Mammals

Only guidance document on which we have real experience

Positive Aspects

•Guidance built on SANCO 4145/2002

•Aligned with 91/414/EEC and 1107/2009

•Working group involved risk assessors and industry

•Led by an experienced Risk Assessor Expert

Difficult Aspects

•Complex

•High failure rate

Particularly for chronic risks to mammals (even for low toxicity products)

Recent ExperienceEFSA Guidance Document on Aquatic Organisms in edge-of-field surface waters

Notified in 2014 – first impressions

Positive Aspects

•Guidance built on existing SANCO Aquatic Ecotox Guidance and additional guidance on high tier studies (ie SETAC eLink & Mesocosm GDs)

•Aligned with 1107/2009 and Uniform Principles:

•Working group led by a very experienced aquatic risk assessment expert

•Overall practicable and should not lead to unexpected conclusions

Tricky Aspects

• Acceptability of Time Weighted Concentrations for assessing Chronic Risk

• Use of Mesocosm data and safety factors applied

•Acceptance of Recovery in Protection Goal

Regulatory Acceptable Concentration: Recovery

Regulatory Acceptable Concentration: NOEC

Noted at the January Standing Committee

But many uncertainties!!• “Protected crops” do not appear in Regulation 1107/2009 – how does

guidance link with “greenhouses” in 1107/2009?

• Sample scenarios provided but not complete and representative. Why not agree scenarios before application?

• Soil risk assessment for greenhouse linked to EFSA Guidance on Soil Risk Assessment (which is not scheduled until 2017/18!)

• Report indicates that an important model used in the guidance does not pass a validation test. Why was it adopted?

And documentation necessary to run the model are not publically available.

Recent ExperienceEFSA Guidance Document on Protected Crops

First ImpressionsEFSA Guidance Document for bees

Still not noted (almost 2 years delay)

VERY Problematic and cannot be complied with

•GD Working Group not led by Bee Expert / only 1 Risk Assessor•Ignores all previous available guidance (EPPO, SANCO)•Includes new data requirements not in 1107 with no guidelines available•Not consistent with Uniform Principles•Very complex (new species, new methods & multiple exposure routes)•Industry Impact Assessment: – Insecticides will be unregisterable and many herbicides and fungicides will also fail.

Honeybee Protection goal impossible to meet Very conservative trigger values and safety factors Field study specification impossible to meet

Non-Target ArthropodsNon-Target Arthropods

Timetable for New EFSA Guidance & Scientific Opinions Indicative deadlines for the publication of deliverables according to official EFSA mandates

Non-target Terrestrial PlantsNon-target Terrestrial Plants

In-soil risk assessmentIn-soil risk assessment

Sediment organismsSediment organisms

Soil PECSoil PEC

Non Target ArthropodsNon Target Arthropods

In soil risk assessmentIn soil risk assessment

Amphibians and reptilesAmphibians and reptilesAmphibians and reptilesAmphibians and reptiles

Effect modeling for RA of for aquatic organismsEffect modeling for RA of for aquatic organismsFERA guidance on aged sorptionFERA guidance on aged sorption

Regulatory Use of BEEHAVE Regulatory Use of BEEHAVE

EC10/NOEC ComparisonEC10/NOEC Comparison

Endangered Species in Risk AssessmentEndangered Species in Risk Assessment

Temporal/spatial recovery of NTO in Env RATemporal/spatial recovery of NTO in Env RA

Guidance Document

Scientific Opinion

Cross Cutting

First ImpressionsEFSA Scientific Opinion on Terrestrial Non-Target Plants

Current major concerns:• Spray drift values potentially increase massively

• Reproductive effects now required = additional 35x safety factor

• Existing Buffer zones to increase by x10

• Protection Goal Proposals: Negligible effects on populations at the edge-of field Protect in-crop biodiversity to support food web

(i.e. protect in-field weeds!!) No effect on endangered species ???

How can Herbicides be registerable under Guidance based on this Opinion?

First ImpressionsEFSA Scientific Opinion on Terrestrial Non-Target Arthropods

Current major concerns:

• Ignored 10+yrs of Regulatory Guidance from ESCORT 1, 2, 3.

• Biodiversity needs to be protected in-field

• Direct and indirect effect from multiple pesticide applications

• Recovery potential should be based on species with low recovery potential!!!

• 40 pages on Protection goals options!!!!

How can insecticides be registerable under Guidance based on this Opinion + Bee Guidance??

Change in EFSA Process moving from Science Opinion to Guidance Document

• EFSA expects Protection Goals to be agreed by Risk Managers within 2 years of publication of the Scientific Opinion:

Process unclear as yet?

Only then will work on the Guidance Document start.

• EC also currently reviewing the process for noting Guidance Documents

EFSA GDs: Lessons learned

• More recent EFSA Expert Groups lack experienced risk assessors Impractical Guidance

• Previous Guidance virtually ignored

• Increased Complexity

• Unrealistic Protection Goals

• Unrealistic level of certainty required Too many «what if» questions - rather than what is likely

• Tiered Risk Assessment approach being undermined Rejection of Field studies

• Requiring studies where no agreed guidelines available

• Over conservative assumptions & safety factors High fail rate

• No Impact Assessment

EFSA GDs: Lessons learned

Inconsistent Application of Guidance

EFSA Neonicotinoid review

• Science Opinion/Draft Guidance was applied

• As a result studies were rejected which substantially exceeded established requirements.

Aged Sorption guidance

• Draft Guidance was available to EFSA in 2012 from UK CRD led Technical Workshop held in 2010 (EFSA were present)

• EFSA has still not adopted

• Focus on needs of risk assessors & risk managers

• Have clear and workable scientific/agronomic based risk assessment scenarios

• Must build on previous experience & guidance

• Require guideline availability for new testing

• Reduce unnecessary complexity

• Derive safety factors and default values which are proportionate and based on data where possible

• Have clearly agreed and practical protection goals

• Consider impact on availability of crop protection solutions

Conclusions

Fit for Purpose Guidance Documents need to:

• Need a clear initial mandate

– It should identify and justify the need for a change

– Mandates should frame what EFSA have to do and what they don’t have to do

• Needs leadership & involvement of experienced ‘users’ in the GD Working Groups

– Define appropriate protection goals (and regulatory needs?)

– Write practical guidance (based on Scientific Opinion)

– Utilises and builds on previous guidance & experience

– Includes an impact analysis

• Protection goals definition is identified as a crucial step

– Should take into consideration the intended agricultural use of the product

– Should be set in the wider context of the impact of agricultural per se

– Protection goals should include risk/benefit considerations (e.g. availability of crop protection solutions)

Recommendations for Improvement

• Testing phase Allowing feedback and adjustments where

necessary How can Industry contribute to the testing phase?

• Define realistic implementation timelines, considering:

Time needed to update risk assessments in New AS and AIR Review Submissions

CRO Testing capacity

Recommendations for Improvement in new GD Implementation

Steps required for workable implementation:

Thank you!